JP5118212B2 - Method for applying pressure to a dressing and a tissue site to collect and contain liquid from the tissue site - Google Patents

Method for applying pressure to a dressing and a tissue site to collect and contain liquid from the tissue site Download PDF

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Publication number
JP5118212B2
JP5118212B2 JP2010549891A JP2010549891A JP5118212B2 JP 5118212 B2 JP5118212 B2 JP 5118212B2 JP 2010549891 A JP2010549891 A JP 2010549891A JP 2010549891 A JP2010549891 A JP 2010549891A JP 5118212 B2 JP5118212 B2 JP 5118212B2
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layer
reduced pressure
tissue site
diverter
dressing
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JP2011514209A (en
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ジャエブ,ジョナサン,ポール
クルサード,リチャード,ダニエル,ジョン
ロビンソン,ティモシー,マーク
ロック,クリストファー,ブライアン
タウト,エイダン,マーカス
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ケーシーアイ ライセンシング インコーポレイテッド
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Priority to US3401308P priority Critical
Priority to US61/034,013 priority
Priority to US4902808P priority
Priority to US61/049,028 priority
Application filed by ケーシーアイ ライセンシング インコーポレイテッド filed Critical ケーシーアイ ライセンシング インコーポレイテッド
Priority to PCT/US2009/036217 priority patent/WO2009111655A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/0023Suction drainage systems
    • A61M1/0049Means preventing overflow or contamination of the pumping systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/00051Accessories for dressings
    • A61F13/00063Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/00051Accessories for dressings
    • A61F13/00068Accessories for dressings specially adapted for application or removal of fluid, e.g. irrigation or drainage of wounds, under-pressure wound-therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/0023Suction drainage systems
    • A61M1/0031Suction control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/0023Suction drainage systems
    • A61M1/0049Means preventing overflow or contamination of the pumping systems
    • A61M1/0052Means preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • A61M1/009Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area having pumping means on suction site, e.g. miniature pump on wound dressing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/008Drainage tubes; Aspiration tips
    • A61M1/0088Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area
    • A61M1/0092Drainage tubes; Aspiration tips with a seal, e.g. to stick around a wound for isolating the treatment area having venting means on or near the tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/0017Wound bandages possibility of applying fluid
    • A61F2013/00174Wound bandages possibility of applying fluid possibility of applying pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00412Plasters use for use with needles, tubes or catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00536Plasters use for draining or irrigating wounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00544Plasters form or structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/15Detection of leaks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7536General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes

Abstract

A reduced pressure dressing for applying reduced pressure treatment to a tissue site includes an interlace layer (1920) adapted to be positioned at the tissue site. An absorbent layer (1928) is in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site. A pump (1810) is in fluid communication with the absorbent layer to deliver a reduced pressure to the tissue site. A cover is positioned over the pump, the absorbent layer, and the interface layer to maintain the reduced pressure at the tissue site, and a liquid-air separator (1940) is positioned between the absorbent layer and the pump to inhibit liquid from entering the pump.

Description

  This application is incorporated by reference herein in its entirety for US provisional application 61 / 034,013 filed March 5, 2008 and US provisional application 61/049 filed April 30, 2008. , Claim the benefit of 028.

  The present invention relates generally to tissue treatment systems, and specifically to a dressing for distributing reduced pressure to a tissue site and collecting and containing fluid from the tissue site.

  Clinical trials and practice have shown that applying reduced pressure near a tissue site promotes and accelerates the growth of new tissue at the tissue site. Although there are many applications for this phenomenon, applying reduced pressure has been particularly successful in the treatment of wounds. This treatment (often referred to in the medical community as “negative pressure wound therapy”, “vacuum therapy” or “vacuum therapy”) provides several benefits, including acceleration of healing and promotion of granulation tissue formation. A reduced pressure is applied to the tissue, usually through a porous pad or other manifold device. The porous pad includes cells or pores that can distribute a vacuum to the tissue to conduct liquid drawn from the tissue. The porous pad may be incorporated into a dressing having other components that facilitate treatment.

  The problems presented by existing collection canisters are solved by the exemplary embodiment systems and methods described herein. In one exemplary embodiment, a reduced pressure treatment system is provided. The reduced pressure treatment system includes a reduced pressure source and a reduced pressure dressing. The dressing includes an interface layer adapted to be disposed on the tissue site and the interface layer and an absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the tissue sites. The diverter layer is disposed between the absorbent layer and the vacuum source, and the diverter layer includes a plurality of openings in fluid communication with the absorbent layer to distribute the vacuum to the absorbent layer. A cover is placed over the diverter layer to maintain a reduced pressure at the tissue site.

  In another exemplary embodiment, the reduced pressure treatment system includes a reduced pressure source and a dressing in fluid in fluid communication with the reduced pressure source. The dressing is adapted to be placed at the tissue site and includes an interface layer that can distribute the vacuum from the reduced pressure source to the tissue site. The absorbent layer is in fluid communication with the interface layer to absorb liquid from the interface layer and the tissue site. A cover is provided to maintain a reduced pressure at the tissue site, and a gas-liquid separator is disposed between the absorbent layer and the cover that inhibits liquid from exiting the dressing.

  In another exemplary embodiment, a vacuum dressing adapted to distribute vacuum to a tissue site is provided. The dressing is adapted to be disposed in an interface layer adapted to be disposed at a tissue site and an absorbent layer in fluid communication with the interface layer that absorbs liquid from at least one of the interface layer and the tissue site. An interface layer formed. The diverter layer is adjacent to the absorbent layer, and the diverter layer is formed from a substantially gas impermeable material. The diverter layer includes a plurality of apertures in fluid communication with the absorbent layer that increases the time that the absorbent layer can dispense a vacuum. A cover is placed over the diverter layer to maintain a reduced pressure at the tissue site.

  In yet another exemplary embodiment, a reduced pressure dressing adapted to distribute reduced pressure to a tissue site includes an interface layer adapted to be placed at the tissue site. The first manifold layer is disposed in fluid communication with the interface layer to distribute the reduced pressure to the interface layer. The absorbent layer is in fluid communication with the first manifold layer and absorbs liquid from at least one of the first manifold layer, the interface layer, and the tissue site. The diverter layer is disposed adjacent to the absorbent layer, and the diverter layer is formed from a substantially gas impermeable material and includes a plurality of spaced apart openings in fluid communication with the absorbent layer. The second manifold layer is disposed in fluid communication with the diverter layer and distributes the reduced pressure to the diverter layer. A cover is provided to maintain a vacuum at the tissue site, the cover including an opening adapted to pass the vacuum through the dressing. The gas-liquid separator is disposed between the second manifold and a cover that inhibits liquid from exiting the dressing.

  In yet another embodiment, a method is provided for collecting fluid in a dressing disposed at a tissue site. The method includes applying a reduced pressure to the tissue site through the dressing, absorbing liquid from the tissue site, and containing the liquid in the dressing. The method further includes preventing liquid from exiting the dressing.

  In another embodiment, a vacuum dressing kit is provided having a dressing element. The dressing element includes an interface layer, an absorbent layer, a diverter layer, and a cover. The dressing element can be incorporated to collect vacuum at the tissue site and collect fluid from the tissue site.

  In yet another exemplary embodiment, the reduced pressure treatment system includes a reduced pressure source, a reduced pressure source, and a dressing in fluid communication with the reduced pressure source. The dressing includes an absorbent layer that is in fluid communication with the tissue site and absorbs liquid from the tissue site when reduced pressure is applied to the dressing by a reduced pressure source. A cover is provided that can maintain a reduced pressure within the dressing and can be expanded from an unexpanded position to an expanded position once the liquid is absorbed by the absorbent layer.

  In yet another embodiment, a reduced pressure dressing adapted to distribute reduced pressure to a tissue site is provided. The reduced pressure dressing includes an interface layer adapted to be disposed at the tissue site and an absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site. The diverter layer is adjacent to the absorbent layer, and the diverter layer is formed from a substantially gas impermeable material. The diverter layer includes a surface area that is less than the surface area of the absorbent layer so that flow is directed around at least one peripheral edge of the diverter layer. A cover is disposed over the diverter layer to maintain the reduced pressure at the tissue site.

  In another exemplary embodiment, a reduced pressure dressing adapted to distribute reduced pressure to a tissue site includes an interface layer adapted to be placed at the tissue site. The absorbent layer is in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site. The diverter layer is in fluid communication with the absorbent layer, and the diverter layer is formed from a material that is substantially gas permeable and liquid impermeable. A cover is placed over the divertor layer at the tissue site to maintain the vacuum.

  Other objects, features and advantages of the exemplary embodiments will become apparent with reference to the following drawings and detailed description.

FIG. 1 illustrates a perspective view of an exemplary embodiment reduced pressure treatment system positioned at a tissue site. FIG. 2 is a front sectional view of the covering material of FIG. FIG. 3 shows an exploded perspective view of the covering material of FIG. FIG. 4 shows a top view of the diverter layer of the dressing of FIG. FIG. 5 shows a top view of a diverter layer of one exemplary embodiment. FIG. 6 shows a top view of the diverter layer of FIG. FIG. 7 shows a perspective view of a diverter layer of one exemplary embodiment. FIG. 8 shows a top view of the diverter layer of FIG. FIG. 9 shows a top view of a diverter layer of one exemplary embodiment. FIG. 10 shows an exploded perspective view of the reduced pressure dressing of one exemplary embodiment. FIG. 11 shows a top view of a drape for use with a vacuum dressing of one exemplary embodiment. FIG. 12 shows a front cross-sectional view of the drape of FIG. FIG. 13 shows a cross-sectional front view of a drape for use with a reduced pressure dressing of one exemplary embodiment. FIG. 14 illustrates a top view of a tissue interface layer for use with a reduced pressure dressing of one exemplary embodiment. FIG. 15 shows a top view of a tissue interface layer for use with a reduced pressure dressing of one exemplary embodiment. FIG. 16 is a graph illustrating vacuum pressure versus time for an exemplary embodiment of a reduced pressure treatment system that applies reduced pressure to a tissue site. FIG. 17 illustrates an exploded perspective view of the reduced pressure treatment dressing of one exemplary embodiment. FIG. 18 illustrates a perspective view of an exemplary embodiment of a reduced pressure treatment system having a dressing with an integral pump disposed at a tissue site. 19 shows a front cross-sectional view of the dressing and pump of FIG. 18 taken along 19-19. FIG. 20 is an exploded perspective view of the covering material and the pump of FIG.

  In the following detailed description of several exemplary embodiments, specific preferred embodiments that form part of the present specification and are capable of practicing the present invention are illustrated by way of example. Reference is made to the accompanying drawings. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and other embodiments may be utilized without departing from the spirit or scope of the invention, It is understood that logical and logical structural, mechanical, electrical and chemical changes can also be made. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the exemplary embodiments is defined only by the appended claims.

  As used herein, the term “reduced pressure” generally refers to a pressure that is less than the ambient pressure at the tissue site being treated. In most cases, this reduced pressure is less than the air pressure where the patient is located. Alternatively, the reduced pressure is less than the hydrostatic pressure corresponding to the tissue at the tissue site. Although the terms “vacuum” and “negative pressure” may be used in describing the pressure applied to the tissue site, the actual vacuum applied to the tissue site is significantly less than the vacuum normally corresponding to a full vacuum. There is a case. Depressurization may initially generate a liquid flow in the region of the tissue site. When the hydrostatic pressure near the tissue site reaches the desired reduced pressure, the liquid flow may subside and then the reduced pressure is maintained. Unless otherwise indicated, the pressure values described herein are gauge pressures. Similarly, a reference to an increase in vacuum typically refers to a decrease in absolute pressure, whereas a decrease in vacuum typically refers to an increase in absolute pressure.

  As used herein, the term “tissue site” includes any one including but not limited to bone tissue, adipose tissue, muscle tissue, nerve tissue, skin tissue, vascular tissue, connective tissue, cartilage, tendon or ligament. Refers to a wound or defect on or within such tissue. The term “tissue site” may further refer to a region of any tissue that is not necessarily injured or missing, but where additional tissue addition or growth promotion is desired. For example, reduced pressure tissue treatment may be used in certain tissue regions for the purpose of growing additional tissue that can be collected and transplanted to another tissue site.

  The decompression treatment system should be applied to large exudative wounds found in patients undergoing emergency or chronic treatment, as well as other severe wounds that are not easily healed without decompression. There are many. Small wounds, low exudation, and less severe wounds are generally treated using advanced dressings instead of reduced pressure treatments. However, these advanced dressings are not adapted for use with reduced pressure and exhibit several disadvantages when used with reduced pressure. For example, these current dressings may not be able to optimally utilize the liquid containment function within the dressing. Furthermore, existing dressings are not configured to properly transmit the reduced pressure, especially when they begin to absorb and contain liquids.

  Currently, the use of reduced pressure therapy is of severe severity because of the need for manpower to monitor and change system components, the need for trained medical staff to monitor treatment, and the cost of treatment. It is not considered a practical or profitable feasible option for low wounds. For example, current decompression treatment systems limit their complexity to those who have little or no expertise to administer the treatment to themselves or others. In addition, due to the size of the current reduced pressure treatment system, not only the mobility of the treatment system but also the mobility of the person to whom treatment is applied is impaired. For example, current reduced pressure treatment systems require the use of a separate canister that contains exudate or other fluid from the tissue site. Also, current reduced pressure treatment systems are typically not disposable after each treatment and require electrical components or other power devices to apply the reduced pressure used in the treatment.

Vacuum Dressing Referring to FIG. 1, the vacuum treatment system 100 of one exemplary embodiment includes a vacuum dressing 104 disposed at a tissue site 108 of a patient. The reduced pressure dressing 104 is in fluid communication with the reduced pressure source 110 by a conduit 112. The conduit 112 may be in fluid communication with the reduced pressure dressing 104 via the tube adapter 116. In the embodiment shown in FIG. 1, the reduced pressure source 110 is a manually operated pump such as a compression bellows pump. In another implementation, the vacuum source 110 may be a motor driven vacuum pump or vacuum pump. In another embodiment, the reduced pressure source 110 may be a power micropump such as a piezoelectric disk pump or a peristaltic pump. In yet another embodiment, the reduced pressure source 110 may be a wall inlet that can be utilized, for example, in hospitals and other medical facilities.

  The reduced pressure source 110 may be housed within a reduced pressure treatment unit that also facilitates the application of reduced pressure treatment to sensors, processing units, warning indicators, memory, databases, software, display units, and tissue sites 108. A user interface may be included. As an example, a sensor or switch (not shown) may be placed at or around the reduced pressure source 110 to measure the supply pressure generated by the reduced pressure source 110. The sensor may communicate with a processing unit that monitors and controls the reduced pressure delivered by the reduced pressure source 110. When the reduced pressure is delivered to the reduced pressure coating material 104 and the tissue site 108, the exudate from the tissue site is kept discharged, the blood flow to the tissue around the tissue site is increased, and the micro strain at the tissue site is reduced. Generating promotes the growth of new tissues.

  With reference to FIGS. 2 and 3, the reduced pressure dressing 104 includes an interface layer 220 adapted for placement at the tissue site 108 and a seal layer 222 that seals the reduced pressure dressing 104 around the tissue site 108. A first manifold layer 224 is in fluid communication with the interface layer 220 and distributes the vacuum to the interface layer 220 and the tissue site 108. An absorption layer 228 is disposed in fluid communication with the first manifold layer 224 and absorbs liquid from at least one of the first manifold layer 224, the interface layer 220, and the tissue site 108. A diverter layer 232 is disposed adjacent to the absorption layer 228. A second manifold layer 236 is disposed in fluid communication with the diverter layer 232, and a gas-liquid separator 240 is disposed adjacent to the second manifold layer 236. A cover 244 or drape is disposed adjacent to the gas-liquid separator 240.

  The interface layer 220 of the reduced pressure dressing 104 is adapted to be in contact with the tissue site 108. The interface layer 220 may be in partial contact with the tissue site 108 to be treated by the reduced pressure dressing 104 or may be in full contact therewith. If the tissue site 108 is a wound, the interface layer 220 may partially occlude or completely occlude the wound.

  The interface layer 220 may have any size, shape, or thickness depending on various factors such as the type of treatment being performed or the nature and size of the tissue site 108. For example, the size and shape of the interface layer 220 may be customized by the user to fill or partially fill the tissue site 108 if the user may customize it to cover a particular portion of the tissue site 108. Also good. Although the interface layer 220 illustrated in FIG. 3 has a square shape, the interface layer 220 may have a circular shape, an elliptical shape, a polygonal shape, an indeterminate shape, or any other shape.

  In one exemplary embodiment, the interface layer 220 is a foam that functions as a manifold that provides reduced pressure to the tissue site 108 when in contact with or near the tissue site 108. The foam material may be either hydrophobic or hydrophilic. In one non-limiting example, interfacial layer 220 is manufactured by Kinetic Concepts, Inc., San Antonio, Texas. Reticulated open cell polyurethane foam, such as GranFooam® dressing available from

  In the example where the interface layer 220 is made of a hydrophilic material, the interface layer 220 also serves to suck up liquid from the tissue site 108 while continuing to supply reduced pressure to the tissue site 108 as a manifold. The wicking characteristic of the interface layer 220 draws fluid from the tissue site 108 by capillary flow or other wicking mechanism. An example of a hydrophilic foam is Kinetic Concepts, Inc. of San Antonio, Texas. Available from V. A. C. There are open cell polyvinyl alcohol foams such as WhiteFoam® dressing. Other hydrophilic foams may include polyether foams. Other foams that may be hydrophilic include hydrophobic foams that have been treated or coated to be hydrophilic.

  The interface layer 220 may further promote granulation formation at the tissue site 108 when reduced pressure is applied through the reduced pressure dressing 104. For example, any or all of the surface of the interfacial layer 220 has a non-uniform, rough or jagged contour that, when subjected to reduced pressure through the interfacial layer 220, causes microstrain and stress at the tissue site 108. May be. These microstrains and stresses have been shown to increase new tissue growth.

  In one embodiment, the interface layer 220 may be constructed from a bioabsorbable material that does not need to be removed from the patient's body after using the reduced pressure dressing 104. Suitable bioabsorbable materials include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). Polymer blends also include, but are not limited to, polycarbonate, polyfumarate and caprolactone. The interface layer 220 may further serve as a scaffold for new cell growth, or a scaffold material may be used with the interface layer 220 to promote cell growth. A scaffold is a substance or structure used to increase or promote cell growth or tissue formation, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA / PGA, coral hydroxyapatite, carbonate, or processed allograft material.

  The seal layer 222 of the reduced pressure coating material 104 includes an opening 231 and seals the periphery of the tissue site 108. The seal layer 222 may serve as a gasket around a portion of the tissue site 108 to prevent the reduced pressure applied to the reduced pressure coating material 104 from leaking out of the reduced pressure coating material 104. Seal layer 222 may also be used to secure interface layer 220 to tissue site 108. If the cover 244 is wrinkled when the cover 244 is applied to the tissue around the tissue site 108, the seal layer 222 assists in maintaining the wrinkled portion of the cover 244.

  The sealing layer 222 may be any size and thickness that can seal the periphery of the tissue site 108. In the example of FIG. 2, the length (L2) and the width (W2) of the seal layer 222 are longer than the length (L1) and the width (W1) of the interface layer 220, respectively. Accordingly, a portion of the seal layer 222 extends beyond the edge of the interface layer 220. These portions may be in direct contact with the tissue surrounding the tissue site 108, thereby sealing around the tissue site 108 and the interface layer 220.

  Although the seal layer 222 shown in FIG. 3 has a square shape, the seal layer 222 may also be any shape that seals around the tissue site 108 or the interface layer 220. Non-limiting examples of other shapes include circular, elliptical, any polygon, indeterminate, or a shape customized to conform to the tissue contour around the tissue site 108 or interface layer 220. included.

  The seal layer 222 may be made of any material that can seal the periphery of the treated portion of the tissue site 108. In one exemplary embodiment, the sealing layer 222 may comprise a hydrogel or may be made of a hydrogel. Seal layer 222 may also include either or both of hydrocolloid or silicon.

  Although the seal layer 222 is shown to be disposed adjacent to the interface layer 220, the seal layer 222 may be disposed adjacent to any layer in the reduced pressure coating material 104. Between the two layers. Further details regarding the placement of the seal layer 222 will be discussed in more detail below with reference to FIG.

  The reduced pressure coating 104 also includes a first manifold layer 224 for distributing reduced pressure to the interface layer 220 and for extracting liquids such as exudates from the interface layer. When the seal layer 222 is disposed adjacent to the interface layer 220, the liquid may be extracted from the tissue site 108 through the opening 231. When a reduced pressure is applied to the reduced pressure dressing 104, the liquid is sucked from the tissue site 108 by the interface layer 220 and extracted by the first manifold layer 224 through the opening 231 of the seal layer 222.

  In one embodiment, the length (L3) and the width (W3) of the opening 231 are shorter than the length (L1) and the width (W1) of the interface layer 220. However, in other embodiments, particularly one in which one or more other layers are disposed between the seal layer 222 and the interface layer 220, the length (L3) and width (W3) of the opening 231. ) Is equal to or longer than the length (L1) and width (W1) of the interface layer 220. The opening 231 shown in FIG. 3 has a square shape, but instead the opening 231 allows the sealing layer 222 to seal while promoting the extraction of liquid from the tissue site 108. It may have any other shape.

  The first manifold layer 224 may have any size, shape, or thickness. For example, the size and shape of the first manifold layer 224 may be customized so that the absorbent layer 228 can be utilized at various levels. Further, the size and shape of the first manifold layer 224 may be the same as the size and shape of the interface layer 220, the seal layer 222, the opening 231, the absorption layer 228 or other layers of the reduced pressure coating material 104. You may customize based on the magnitude | size and shape of other components of this.

  The first manifold layer 224 is a biocompatible porous material that can distribute reduced pressure to the tissue site 108. The first manifold layer 224 may be made of foam, gauze, felt mat, or any other material suitable for a particular biological application. The first manifold layer 224 includes a plurality of flow channels or channels that facilitate the distribution of reduced pressure to or distribution of fluid from the tissue site 108. In one embodiment, the first manifold layer 224 is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a reticulated open cell polyurethane foam such as GranuFoam® dressing. If open-cell foam is used, the porosity can be about 400 to 600 microns, or any other porosity that can properly deliver and deliver a vacuum. The flow channel allows fluid communication to the entire portion of the first manifold layer 224 having open cells. Cells and flow channels may include regular and irregularly varied shapes and sizes, as long as the shapes and sizes may be uniform. As the shape and size of the cells in the first manifold layer 224 change, the flow channel also changes, so these characteristics can be used to change the flow characteristics of the liquid through the first manifold layer 224. Also good. The first manifold layer 224 may be either hydrophobic or hydrophilic. In one embodiment, the first manifold layer 224 may be made of the same material as the interface layer 220.

  In one embodiment, the first manifold layer 224 includes a liquid such as exudate from the tissue site 108 such that the first manifold layer 224 fills the wound site or otherwise contacts the tissue site 108. It may be made of a material that expands when contacted. In this embodiment, the first manifold layer 224 allows the interface layer 220 to be removed, thereby simplifying the construction of the vacuum dressing 104 and reducing the thickness or profile of the dressing. There may be.

  The absorbent layer 228 of the reduced pressure dressing 104 is disposed adjacent to the first manifold layer 224 to contain and absorb the liquid distributed by the first manifold layer 224. The first manifold layer 224 facilitates the liquid from the tissue site 108 to move radially outward toward the edge of the first manifold layer 224, as schematically illustrated by the multidirectional arrow 239; Ensure that the liquid is more evenly distributed throughout the absorbent layer 228. The more uniformly the liquid is distributed across the surface of the absorbent layer 228, the more liquid will be retained by the absorbent layer 228.

  As used herein, “surface area” of a layer refers to an area measurement of the layer that is measurable in a plane that is placed adjacent to or in contact with another layer. In the example shown in FIG. 3, the surface areas of the first manifold layer 224 and the absorption layer 228 are measured by multiplying the length and width of each layer, and the length and width are the length (L3) of the opening 231. And measured in a plane substantially parallel to the plane including the width (W3).

  The surface area (defined as L3 × W3) of the opening 231 in FIG. 3 may be smaller than the surface area of the first manifold layer 224 and the surface area of the absorption layer 228. When the first manifold layer 224 does not distribute liquid radially toward the edge of the first manifold layer 224, the absorbent layer 228 is mainly a part of the absorbent layer 228 having the same size as the opening 231. Will absorb liquid. However, because the first manifold layer 224 can distribute the liquid from the tissue site 108 radially in the direction indicated by the multidirectional arrow 239, the greater surface area of the absorbent layer 228 is exposed to the liquid and more liquid is dispensed. An absorbent layer 228 can be accommodated. The reduced pressure dressing 104 is primarily designed for use with reduced pressure, but the liquid from the tissue site 108 is distributed in the direction indicated by the multidirectional arrow 239, whether or not the reduced pressure is applied. There is a case. Even when the reduced pressure coating 104 is not depressurized, the absorbent layer 228 may be more thorough using the first manifold layer 224.

  The absorbent layer 228 is adapted to absorb fluid such as exudate from the tissue site 108 through the interface layer 220 and the first manifold layer 224 through the opening 231 of the seal layer 222. The absorbent layer 228 is also adapted to collect and deliver reduced pressure to the tissue site 108 through the layer. The absorbent layer 228 may be made of any material that can absorb liquid such as exudate from the tissue site 108. In one embodiment, the absorbent layer 228 may be made of superabsorbent fibers. The superabsorbent fiber may hold the liquid according to the physical or chemical change of the fiber or may be combined with the liquid. In one non-limiting example, superabsorbent fibers include Technical Absorbents®, Ltd. Super Absorbent Fiber (SAF) material may be included. Absorbent layer 228 may be a sheet or mat of fibrous material in which the fibers absorb liquid from tissue site 108. The structure of the absorbent layer 228 containing the fibers may be woven or non-woven. The fibers of the absorbent layer 228 may gel when contacted with a liquid, thereby collecting the liquid. The space or gap between the fibers may allow the reduced pressure applied to the reduced pressure dressing 104 to be transmitted into and through the absorbent layer 228. In one embodiment, the fiber density of the fibers in the absorbent layer 228 may be about 1.4 g / mm.

  The absorption layer 228 may have any size, shape, or thickness. If the vacuum covering material 104 requires additional liquid capacity, an absorbent layer 228 having a larger size or thickness may be used. In another example, the size and thickness of the absorbent layer 228 may be reduced in terms of space saving, convenience, compactness, or cost effectiveness.

  The reduced pressure coating 104 is also disposed adjacent to the diverter layer 232 disposed adjacent to the absorbent layer 228, the second manifold layer 236 disposed adjacent to the diverter layer 232, and the second manifold layer 236. The gas-liquid separator 240 may be included. The diverter layer 232 includes a plurality of holes 247, and a reduced pressure is applied from the reduced pressure source 110 (see FIG. 1) through the holes. The reduced pressure is distributed to the diverter layer 232 by the second manifold layer 236. To apply reduced pressure to various portions of the absorbent layer 228 to improve the ability of the absorbent layer 228 to continue to transmit reduced pressure to the tissue site 108 and absorb more liquid from the tissue site 108 The holes 247 may be arranged in a pattern. In the embodiment shown in FIG. 3, a plurality of holes are formed in the peripheral portion of the diverter layer 232 away from the center of the diverter layer 232 so that the pressure is applied to the portion of the absorbent layer 228 away from the center region of the absorbent layer 228. 247 is arranged in a pattern. The diverter layer 232 acts in combination with the first manifold layer 224 to ensure that the absorption capacity and absorption efficiency of the absorption layer 228 are improved as compared to an absorption layer not used in combination with the diverter layer. The diverter layer 232 also increases the time that the absorbent layer 228 can collect and deliver reduced pressure within the dressing 104 by improving the distribution of liquid throughout the absorbent layer 228.

  The diverter layer 232 may be made of any material that improves the reduced pressure transmission and containment capacity of adjacent absorbent layers. For example, the diverter layer 247 may be made of a material that is substantially impermeable to liquids and gases. Alternatively, the material constituting the diverter layer 232 may have a predetermined moisture permeability that matches the gas permeability. In either example, the diverter layer 232 may still include a pattern of holes to transmit more liquid or gas than is possible with the gas permeable material comprising the diverter layer 232. . However, it should be noted that the gas permeability rather than the liquid permeability of the diverter layer 232 may improve the transmission of reduced pressure through the covering material while directing the liquid flow around or near the diverter layer 232. There is a need.

  In the embodiment shown in FIG. 3, the reduced pressure creates a liquid flow through the hole 247. The liquid flow through the hole 247 directs the liquid drawn into the absorption layer 228 in a direction away from the central region of the absorption layer 228. Further, the presence of the hole 247 and the liquid flow through the hole 247 reduces the liquid absorption rate in the central region of the absorption layer 228 so that the absorption layer 228 can absorb liquid from a larger area. Sometimes it becomes. Thus, the gas and liquid do not move only through the center of the absorbent layer 228 or through the center of other layers located closer to the tissue site 108 than the diverter layer 232. Since both the gas and liquid are directed radially outward toward the edge of the absorbent layer 228, more portions of the absorbent material are exposed to the liquid from the tissue site 108, and thus more portions of the absorbent layer 228. May be used to contain or collect more liquid.

  By utilizing the absorption layer 228 more effectively, the reduced pressure coating material 104 can be used for a longer period without having to dispose of the reduced pressure coating material 104. The need to distribute gases and liquids towards the edges of the absorbent layer 228 may be further increased when reduced pressure is applied because of the rate at which the liquid flows away from the tissue site 108 through the reduced pressure dressing 104. There is.

  The diverter layer 232 has been mainly described so far as an aid in diverting the liquid pressure or diverting the liquid flow towards the peripheral region of the absorbent layer 228. However, on the other hand, the diverter layer 232 instead assists in redirecting the vacuum toward any particular area of the absorbent layer 228 (ie, the target area) to facilitate liquid absorption within the target area. It is also possible to configure as described above. For example, if the tissue site and the coating material are configured to naturally collect liquid in the peripheral region of the specific absorption layer, configure the divertor layer to promote liquid collection in the central region of the absorption layer Is possible. In this specific example, the central region is the target region.

  Still referring to FIGS. 2 and 3, the second manifold layer 236 distributes the vacuum more evenly across the surface of the diverter layer 232. The second manifold layer 236 may be made of any material capable of dispensing or collecting liquid. In one example, the second manifold layer 236 may be made of the same or similar material as the first manifold layer 224. In this example, the second manifold layer 236 may include a plurality of interconnected cells that form a porous foam. The second manifold layer 236 may also collect liquid from the tissue site 108 such as exudate that is not absorbed by the absorbent layer 228. The second manifold layer 236 may have any size, shape, or thickness.

  In one embodiment of the reduced pressure coating 104, the gas / liquid separator 240 may be a hydrophobic filter that inhibits or prevents liquid movement through the gas / liquid separator 240. Alternatively, if the gas-liquid separator 240 can be a gravity barrier system, the apparatus includes a hydrophilic surface that facilitates condensation or other separation of the liquid from the liquid stream as it moves across the surface. It may be. Other examples of gas-liquid separator 240 can separate liquid from sintered metal, sintered nylon, or liquid streams, or allow or prevent gas movement while inhibiting or preventing liquid movement. Any other material or device that may be included may be included.

  The gas-liquid separator 240 prevents liquid from reaching the tube adapter 116 or conduit 112 (see FIG. 1) by suppressing or preventing liquid flow. The gas-liquid separator 240 also prevents the liquid from reaching the vacuum source 110 by preventing the liquid from reaching the conduit 112.

  The gas-liquid separator 240 may prevent reduced pressure transfer to the tissue site 108 when saturated, clogged, inhibited, and / or wetted by liquid from the tissue site 108. The gas-liquid separator 240 may also prevent reduced pressure movement to the tissue site 108 when the layer in contact with the gas-liquid separator 240 is saturated with liquid. For example, in a specific embodiment, when the absorption layer 228 is in contact with the gas-liquid separator 240, the gas-liquid separator 240 may prevent the reduced pressure movement when the absorption layer 228 is saturated with liquid. Due to the presence of the diverter layer 232 between the gas-liquid separator 240 and the absorption layer 228, the period until the gas-liquid separator 240 inhibits the movement of the reduced pressure becomes longer.

  The gas-liquid separator 240 may have any size, shape, or thickness. In one example, the gas-liquid separator 240 may be smaller than the other layers in the vacuum dressing 104 for cost-effective reasons. The gas-liquid separator 240 may also be wider than the tube adapter 116 and the opening 260 so that liquid from the tissue site 108 cannot reach the tube adapter 116 or the opening 260 in the cover 244. .

  The cover 244 of the reduced pressure coating material 104 covers at least a part of the reduced pressure coating material 104. In one embodiment, the cover 244 may completely cover multiple layers of the vacuum dressing 104. In this embodiment, the cover 244 may provide a guarantee or assistance when securing the reduced pressure dressing 104 to the tissue site 108 and maintaining a sealed condition around the tissue site 108. In this regard, both the cover 244 and the seal layer 222 may cooperate to form a sealed state around the tissue site 108. Cover 244 may also provide a protective barrier to vacuum dressing 104 and tissue site 108.

  In the embodiment shown in FIGS. 2 and 3, the cover 244 may cover and secure components and layers between the cover 244 and the diverter layer 232. In this embodiment, the cover 244 may be fixed by being bonded to the diverter layer 232 or may be fixed by other methods. The diverter layer 232 may be made of the same material as the cover 244, in which case the diverter layer is secured to either or both of the seal layer 222 and tissue in or near the tissue site 108. The diverter layer 232 of this embodiment secures and seals the components and layers directly below the diverter layer 232 at the tissue site 108.

  In one embodiment, the cover 244 may be an adhesive drape. The adhesiveness of the cover 244 may be due to the nature of the material forming the cover 244, or may be due to an adhesive layer disposed on the surface of the cover 244. Any portion of the cover 244 may include an adhesive. For example, the entire tissue facing the side of the cover 244 may include an adhesive. If the cover 244 comprises an adhesive, the cover 244 may adhere to at least a portion of any layer or component of the tube adapter 116, the tissue surrounding the tissue site 108, or the reduced pressure dressing 104. In another embodiment, only the periphery of the tissue facing the side of the cover 244 may include an adhesive. In this embodiment, the peripheral portion covered with the adhesive may be adapted to adhere to any of the diverter layer 232, the seal layer 222, and the tissue surrounding the tissue site 108.

  In yet another embodiment, the cover 244 may be designed to adhere to a dry surface, although the cover 244 does not adhere to a wet surface. Therefore, when the cover 244 is applied, the cover 244 does not stick to wet gloves or hands, which facilitates handling of the cover 244 until the cover 244 is applied to a dry tissue site such as a dry part around the wound. Become. The cover 244 may be any size, shape or thickness. In one example, if the cover 244 may be larger than any layer or component of the reduced pressure dressing 104, in another example, the size of the seal layer 222 may be larger than the size of the cover 244.

  The reduced pressure may be applied to multiple layers of the reduced pressure dressing 104 through the openings 260 in the cover 244. In the example of FIGS. 2 and 3, the opening 260 is shown as being located in the center of the cover 244. However, the opening 260 may be disposed anywhere on the cover 244 including the peripheral portion of the cover 244 adjacent to the edge of the cover 244. Although the opening 260 is shown in a circular shape, the opening 260 may have any shape. In one example, the shape of the opening is adapted to follow the contour of one or more portions of the tube adapter 116.

Tube adapter 116 provides an interface between conduit 112 and vacuum dressing 104.
Specifically, the tube adapter 116 is in fluid communication with the conduit 112 such that the conduit 112 transmits reduced pressure to the reduced pressure dressing 104 and the tissue site 108 via the tube adapter 116.

  With reference to FIGS. 1 and 2, the tube adapter 116 may be a conventional connector pad adapted to abut the opening 260 or to be partially disposed within the opening. Alternatively, the tube adapter 116 may have a flat dome shape or any other shape. The flat outer shape of the tube adapter 116 may help maintain the compactness and user convenience of the reduced pressure dressing 104. The tube adapter 116 includes a flange 266 disposed around the tube adapter 116. In the embodiment shown in FIGS. 2 and 3, the tissue facing the side of the cover 244 near the opening 260 ensures that the tube adapter 116 is secured to at least one layer or component of the reduced pressure dressing 104. , May be adapted to be able to adhere to the flange 266.

  Although not shown in FIGS. 2 and 3, in one embodiment, the reduced pressure dressing 104 includes a deodorizing filter. The deodorizing filter retains odor and prevents leakage from the reduced pressure coating material 104. The deodorizing filter may be a carbon deodorizing filter containing activated carbon. In one example, the deodorizing filter is an activated carbon cloth. The deodorizing filter may be disposed anywhere in the reduced pressure coating material 104, such as between the cover 244 and the gas-liquid separator 240.

  The reduced pressure dressing 104 may further include an indicator (not shown) that alerts the user when the reduced pressure dressing 104 has reached its maximum liquid capacity and needs to be removed from the tissue site 108. In one embodiment, the indicator may be a chemical or other substance that can change its visual appearance or some other characteristic in the presence of moisture. For example, in a layer between the cover 244 and the absorbent layer 228 so that the liquid will completely saturate the absorbent layer and the visual color of the indicator changes as it passes through the absorbent layer and contacts the indicator. One indicator may be arranged. In one embodiment, the indicator may form part of the gas-liquid separator 240. Instead, the indicator may be part of a separate indicator layer that is placed anywhere in the dressing to indicate the presence of moisture in a particular area. The indicator may be combined with another layer of dressing that is transparent in color so that the location of the indicator is visible to the user.

  The cover 244, the gas-liquid separator 240, the manifold layers 224 and 236, the diverter layer 232, the absorbent layer 228, the seal layer 222, and the interface layer 220 are substantially square in FIG. Any of the components, as well as other layers disclosed herein in connection with other embodiments, may have any shape necessary to provide proper reduced pressure treatment to the tissue site 108. . For example, these components and layers may be polygonal, rectangular, circular, elliptical, indeterminate, customized, or any other shape.

  While the various layers of the vacuum dressing 104 have been described so far as being “adjacent” to other layers, the term “adjacent” may refer to the layers being directly adjacent, Or it may indicate that the layers are arranged with other intervening layers interposed therebetween. In general, the term “layer” refers to a portion or region of a dressing that has different material properties or functions than other portions or regions of the dressing (ie, other layers). The term “layer” is not intended to be spatially limited in any way. Properties and functions corresponding to a particular layer may be combined with properties and functions of another layer to form a single layer having a plurality of different properties and functions. More specifically, for example, multiple layers may be physically or chemically combined or combined to form a single layer without affecting the original material properties or functions of the original component. Also good. Conversely, a specific layer of the dressing described herein may be divided into a plurality of layers each having similar properties or functions.

  With reference to FIG. 2 more specifically, the specific arrangement of the multiple layers of the reduced-pressure coating material 104 will be described in more detail. The tissue facing the side 316 of the interface layer 220 is shown in contact with the tissue site 108. In one example, the tissue facing the side 316 of the interface layer 220 has a non-uniform surface that promotes granulation at the tissue site 108 when a vacuum is applied through the interface layer 220. The non-uniform surface includes a fibrous surface that produces microstress and strain at the tissue site 108.

  The seal layer 222 may be disposed anywhere between the cover 244 and the interface layer 220, such as between the absorbent layer 228 and the interface layer 220. In the example of FIG. 2, the seal layer 222 is disposed between the first manifold layer 224 and the interface layer 220 such that a portion of the tissue facing the side surface 327 of the seal layer 222 contacts the interface layer 220. ing. Specifically, the structure facing the side surface of the inner edge of the sealing layer 222 forming the opening 231 is in contact with the interface layer 220.

  Seal layer 222 also includes an overhang 329 that extends beyond the edge of interface layer 220. The overhang portion 329 may be adapted to attach to or otherwise contact the tissue site 108 such that a portion of the tissue site 108 is sealed. For example, the overhang portion 329 may adhere to the portion around the wound site or otherwise contact so as to seal the wound site.

  Further, the first manifold layer 224 may be disposed anywhere in the reduced pressure coating material 104. In one example, the first manifold layer 224 is disposed between the interface layer 220 and the absorbent layer 228. In the non-limiting example of FIG. 3, the first manifold layer 224 is disposed between the seal layer 222 and the absorbent layer 228. Specifically, the portion of the tissue facing the side surface 336 of the first manifold layer 224 contacts the opening 231 of the seal layer 222. In this example, the drape facing the side surface 337 of the first manifold layer 224 contacts the absorbing layer 228.

  In the embodiment shown in FIG. 2, the absorbent layer 228 is shown disposed between the diverter layer 232 and the first manifold layer 224. The first manifold layer 224 is in contact with the tissue facing the side surface 342 of the absorbent layer 228, and the diverter layer 232 is in contact with the drape facing the side surface 343 of the absorbent layer 228. In one example, the diverter layer 232 may be disposed between the absorbent layer 228 and the cover 244. The tissue facing the side surface 347 of the diverter layer 232 contacts the absorbing layer 228, and the drape facing the side surface 348 of the diverter layer 232 contacts the second manifold layer 236.

  The second manifold layer 236 may be disposed between the absorbent layer 228 and the cover 244 or may be disposed between the diverter layer 232 and the cover 244. In FIG. 2, the second manifold layer 236 is disposed between the gas-liquid separator 240 and the diverter layer 232. The diverter layer 232 is in contact with the tissue facing the side surface 352 of the second manifold layer 236, and the gas-liquid separator 240 is in contact with the drape facing the side surface 353 of the second manifold layer 236.

  The gas-liquid separator 240 may be disposed between the absorption layer 228 and the cover 244 or may be disposed between the second manifold layer 236 and the cover 244. In FIG. 2, the tissue facing the side surface 356 of the gas-liquid separator 240 abuts on the second manifold layer 236. A part of the drape facing the side surface 357 of the gas-liquid separator 240 abuts on the tube adapter 116.

  The tissue facing the side surface 351 of the tube adapter 116 abuts on the gas-liquid separator 240. A part of the tube adapter 116 is shown protruding from an opening in the cover 244. A flange 266 of the tube adapter 116 is sandwiched between the cover 244 and the gas-liquid separator 240, and the tube adapter 116 is fixed to at least one of a plurality of layers such as the gas-liquid separator 240 by the cover 244. To be. As shown in FIG. 2, the gas-liquid separator 240 may be wider than the opening 260 in the cover 244, and the second manifold layer 236 may be wider than the gas-liquid separator 240.

  The cover 244 may cover all or part of the reduced pressure coating material 104. For example, both ends of the cover 244 may be terminated at positions on the protruding portion 329 of the seal layer 222. The cover 244 may also terminate at a location on the tissue site 108 as indicated by the dashed line 380.

  Referring to FIG. 4, the diverter layer 232 includes patterned holes or other openings to apply a vacuum to portions (not shown) of the absorbent layer 228. The holes have different diameters. More specifically, the diameter of the hole 450 is larger than the diameter of the hole 247. In operation, the diverter layer 232 derives more vacuum at the four corners of the square absorbent layer 228 to further improve the transmission capability of the absorbent layer 228. This is because the liquid diffuses radially outward from the center of the absorption layer 228, so that the four corners of the absorption layer 228 are the last part of the absorption layer 228 that is filled with the liquid.

  With reference to FIGS. 5 and 6, the diverter layer 545 of one exemplary embodiment may be made of any material that expands when in contact with a liquid. For example, the diverter layer 545 may be made of hydrogel. The diverter layer 545 may also include a hydrocolloid material, silicon, or silicone material. The diverter layer 545 includes a hole 547 or other opening. The length of each arrow extending from each hole 547 represents the relative amount of flow or vacuum allowed through each hole. In FIG. 5, an equal amount of flow or reduced pressure is transmitted from each hole 547.

  Depending on the application of reduced pressure, more exudate may be generated from the tissue in a region away from the center of the dressing. In such a case, more liquid may pass through a part of the hole portion 547 disposed over the main exudation point. In the example shown in FIG. Accordingly, the hole 648 is shown in a reduced, expanded, or substantially closed shape due to contact with fluid from the tissue site. Restricting the holes 648 causes a selective flow through the remaining holes 547, thereby making the flow uniform across adjacent absorbent layers in the dressing. Specifically, the hole 547 of the diverter layer 545 shown in FIG. 6 transmits more decompression than the hole 648. By making the flow and decompression uniform in this way, the absorption layer such as the absorption layer 228 in FIGS. 2 and 3 becomes more effective regardless of the position of the main exudation point in the tissue site or the liquid absorption pattern by the absorption layer. May be used.

  Referring to FIGS. 7 and 8, in one exemplary embodiment, the diverter layer 745 protrudes from the surface of the diverter layer 745 and has a plurality of ridges 785 extending radially outward from the center of the diverter layer 745 toward the periphery. And a plurality of channels 787 are formed or defined therebetween. The ridge 785 may be curved and may converge at the center of the diverter layer 745. The ridge surface of the diverter layer 745 is in contact with an absorbing layer (not shown), and when the channel 787 is closed, the paths 887 and 888 (FIG. 8) radially spread between the central portion and the peripheral portion of the diverter layer 745. Is to be formed. In FIG. 8, since each path 887 is shown in an unblocked form, a substantially equal amount of reduced pressure flows freely from each path. However, depending on the application of reduced pressure, liquid from the tissue site 108 (not shown) may fill the path 888 and become occluded. For example, this phenomenon may occur when the main exudation point from the tissue site is located away from the center of the covering material such as the diverter layer 745. Because more liquid flows from the path 888 than the path 887, the path 888 is filled with liquid and is saturated by the saturated portion of the absorbent layer 228 that is in contact with the path 888 as shown by the shaded portion 889. Blocked. Accordingly, as shown by the arrow on the diverter layer 745, more decompression is applied via the path 887 than the blocked path 888. The path 887 then becomes a selective path for reduced pressure and liquid flow until the entire absorbent layer 228 adjacent to the diverter layer 745 is saturated. By making the flow uniform in this way, the absorption layer 228 is used more effectively regardless of the position of the main exudation point in the tissue site or the liquid absorption pattern by the absorption layer 228.

  Referring to FIG. 9, a diverter layer 945 of one exemplary embodiment is shown. The diverter layer 945 includes a patterned hole 947 or an opening thereof in the periphery of the diverter layer 945. However, in contrast to the diverter layer 232 of FIGS. 2 and 3, the diverter layer 945 includes a portion 931 that does not include a hole 947. The portion 931 can be aligned with a tube adapter (similar to the tube adapter 116) disposed at a position away from the center. Depressurization is applied to the coating material via the tube adapter, so that even if one or more layers are present, the presence of a hole directly below the tube adapter can cause a hole adjacent to the tube adapter to be directly below the hole. In some cases, a large pressure reduction may be applied. By eliminating the hole in the portion 931 of the diverter layer 945 adjacent to and immediately below the tube adapter, a reduced pressure is applied through all the remaining holes 947, and the reduced pressure is more evenly distributed to the absorbent layer 228.

  Although the diverter layer of FIGS. 4-9 has been shown and described so far as including a substantially circular hole, the diverter layer may instead be replaced with, for example, a slit, channel, perforation, or any other opening. Any shape or size opening may be included. Alternatively, a diverter layer having no opening may be provided so that the peripheral dimension and / or surface area is smaller than that of the absorbent layer. A diverter layer that is shorter or wider than the absorbent layer is the same as placing an opening near the edge of a larger diverter layer to ensure liquid flow movement at the peripheral edge of the diverter layer Has an effect.

  Referring to FIG. 10, an example embodiment vacuum dressing 1000 is shown. The reduced pressure coating 1000 is similar to the reduced pressure coating 104 of FIGS. Although the tube adapter 116 or cover 244 of FIGS. 2 and 3 is not shown in the vacuum dressing 1000, the absorbent layer 228 and the diverter layer 232 are included. Further, the reduced-pressure coating material 1000 also includes a thermal moisture exchange (HME) foam 1015 that is a non-limiting example of the interface layer 220 in FIGS. 2 and 3. The HME foam 1015 may be a hydrophilic foam that draws liquid from the tissue site 108. The HME foam 1015 may also distribute the vacuum to the tissue site. In one example, the tissue facing the side of the HME foam 1015 has a non-uniform surface so that granulation formation is promoted at the tissue site 108 when reduced pressure is applied through the HME foam 1015. Each arrow in FIG. 10 represents the flow of either or both of gas and liquid when the reduced pressure coating material 1000 is subjected to reduced pressure. The arrows indicate how the diverter layer 232 facilitates the distribution of gases and liquids throughout the vacuum dressing 1000 in order to make more efficient use of the absorbent layer 228. For example, the arrow indicates that due to the presence of the diverter layer 232, the liquid is drawn radially outward toward the edge of the absorption layer 228, and the absorption capacity of the absorption layer 228 is utilized more effectively. ing.

  The reduced pressure coating material 1000 is also disposed adjacent to the second absorbent layer 1040 disposed adjacent to the diverter layer 232 on the side facing the first absorbent layer 228 and adjacent to the opposite side of the second absorbent layer 1040. The second HME layer 1041 is also included. The second HME layer 1041 may be open cell and / or hydrophilic foam. In one example, the HME layer 1041 is made of the same material as the HME foam 1015. Liquid from the tissue site 108 (not shown) is absorbed and transferred to the absorbent layer 228 as it is drawn into the HME foam 1015. After the liquid is absorbed by the absorption layer 228, the liquid is drawn through the hole 247 of the diverter layer 232, whereby the liquid is diffused and the absorption layer 228 is further utilized. In a non-limiting example where a hydrogel diverter layer such as the diverter layer 545 of FIG. 5 is used in place of the diverter layer 232, the gel in the hole 247 causes the liquid to move around and be distributed within the absorbent layer 228. Blocking can occur. The second absorbent layer 1040 further absorbs any liquid flowing through the diverter layer 232, whereas the second HME layer 1041 collects and distributes the vacuum across the second absorbent layer 1040. In some cases, the second HME layer 1041 may receive a compressive force when a reduced pressure is applied through the reduced pressure coating material 1000. Regardless of such compressive force, the second HME layer 1041 nevertheless includes an open pressure channel that allows the second HME layer 1041 to transmit reduced pressure to other parts of the reduced pressure dressing 1000. But you can. A filter such as a gas-liquid separator 240 may be disposed on the HME layer 1041 in order to suppress or prevent the liquid from leaking from the reduced pressure coating material 1000.

  Referring to FIGS. 11 and 12, a drape 1125 (or cover) is provided that can be used in combination with a reduced pressure coating material such as, for example, the reduced pressure coating material 104 of FIGS. The drape 1125 includes an elastic portion 1110. The elastic portion 1110 is disposed at the center of the drape 1125. The elastic portion 1110 may be made of any elastic material. 11 and 12, the opening is not shown on the elastic part 1110, but the elastic part 1110 may include an opening such as the opening 260 in FIG. The opening may be disposed anywhere on the elastic portion 1110. The elastic portion 1110 is coupled to the peripheral portion 1115 of the coupling region 1120. The bond in bonding region 1120 may be formed using any bonding method. For example, the elastic portion 1110 may be bonded to the peripheral portion 1115 of the bonding region 1120 with an adhesive or may be bonded by other methods.

  Peripheral portion 1115 may be made of any material including elastic or inelastic materials. In one example, the peripheral portion 1115 includes an opening. The tissue facing the side surface 1122 of the peripheral portion 1115 may include an adhesive so that the drape 1125 can be used to cover and secure one or more layers, such as the layer of the vacuum dressing 104. In another embodiment, the elastic portion 1110 and the peripheral portion 1115 are both made of the same material and are continuous with each other such that a bond between the elastic portion 1115 and the peripheral portion 1115 of the bonding region 1120 is not required. May be.

  As shown in FIG. 12, the elastic portion 1110 can expand to a plurality of positions from an unexpanded position indicated by a solid line to an expanded position 1110a indicated by a broken line. As the vacuum dressing using the drape 1125 is filled with liquid, the elastic portion 1110 moves to the expanded position 1110a. The ability of the drape 1125 to move to the expanded position 1110a allows additional space in the reduced pressure dressing to accommodate liquid from the tissue site 108 (not shown).

  Instead of a drape having an elastic portion, the drape 1125 may be made of an inelastic material that can be plastically deformed into an expanded position when liquid is collected in the dressing. Alternatively, drape 1125 may include a combination of elastic and inelastic materials, and expansion may occur based on both elastic and plastic deformation of the material.

  Referring to FIG. 13, the drape 1325 (or cover) includes a pleat portion 1310 disposed in the center of the drape 1310. The pleated portion 1310 may be made of an elastic material or an inelastic material. The pleated portion 1310 also includes one or more pleats 1312 or ridges. The pleats may be located on either side or any side of the pleated portion 1310. Also, in FIG. 13, one pleat is shown on each side of the pleated portion 1310, but any number of pleats may be included on each side of the pleated portion 1310. It may be formed. The pleated structure of the pleated portion 1310 allows the pleated portion 1310 to expand when liquid is contained within the underlying reduced pressure coating.

  The drapes 1125 and 1325 of FIGS. 11-13 can expand to accommodate liquid collection and containment in the reduced pressure dressing. It is also important to note that the drapes 1125 and 1325 can maintain a reduced pressure in the dressing before, during and after expansion.

  Referring to FIGS. 14 and 15, one exemplary embodiment of interface layers 1400 and 1500 are shown. The interfacial layers 1400 and 1500 are easy tearable, including semi-perforated perforations 1405 and 1505 that can easily tear and resize the interfacial layers 1400 and 1500 for use in a coating such as the reduced pressure coating 104. Sheet foam material. In one example, when the interface layers 1400 and 1500 are half punched, the punching die penetrates the thickness of the foam material substantially but does not penetrate completely. This provides a weak break for tearing, but the foam can still maintain its shape. In FIG. 14, the half-cut perforations 1405 are a series of concentric circles. An appropriately sized interface layer may be torn along any one of the concentric circles. In FIG. 15, the half perforation 1505 is a continuous spiral-like perforation. If it is necessary to adjust the size of the interface layer before using with the covering material, the half-cut perforation 1505 may be torn along the continuous perforations.

  Half-cut perforations 1405 and 1505 provide weak cut lines that can tear the interface layer. When using a portion of the interface layers 1400 and 1500 with the dressing, some perforation may still remain in the interface layer. However, regardless of the presence of such perforations, the interface layer can still maintain the desired shape and effectively perform the functions of the interface layer described herein.

Referring to FIG. 16, a graph 1600 illustrating exemplary characteristics of a vacuum dressing is shown. Graph 1600 shows the pressure drop measured as a function of time at the interface layer of the vacuum coating with the liquid added at a rate of about 2 milliliters / hour. Specifically, graph 1600 is measured at the interfacial layer of the dressing having an area of about 8 cm 2 and containing an HME foam, with the second superabsorbent fiber layer dressing mounted on the large tube during the test. Pressure. The reduced pressure applied to the dressing throughout the test is consistently 125 mmHg. As the coating fills with liquid over time, the interfacial layer pressure eventually drops, and the coating can no longer properly deliver the vacuum. The graph 1600 represents only the properties of one particular vacuum coating, and other exemplary embodiments of the coating described herein exhibit properties that are different from those shown in the graph 1600. In some cases.

  Referring to FIG. 17, an exemplary embodiment dressing 1700 includes an interface layer 1715. In contrast to the interface layer 220 of FIG. 2, the interface layer 1715 is larger than the other layers in the dressing. The dressing 1700 includes an absorbent layer 228 on the tissue interface layer 1715 and a diverter layer 232 on the absorbent layer 228. In contrast to the vacuum dressing 104, the dressing 1700 includes another absorbent layer 1740 on the diverter layer 232. Absorbing layer 1740 is similar to absorbing layer 228. In order to increase the absorptivity of the covering material 1700, an absorption layer 1740 may be added. The absorbent layer 1740 may be used to collect liquid that has passed through the absorbent layer 228 or was not absorbed by the absorbent layer.

  The dressing 1700 includes a second manifold layer 236 on the absorbent layer 1740 and a gas-liquid separator 240 on the second manifold layer 236. The dressing 1700 also includes a seal layer 1724 (similar to the seal layer 222 of FIG. 2) on the gas-liquid separator 240. The seal layer 1724 has a circular opening 1730, but the circular opening 1730 may have any shape. The dressing 1700 may also include a tube adapter 1740 and a cover 244. The tube adapter 1740 may have a flat dome shape or any other shape.

  In one embodiment, the components of dressing 1700 adapted to contact the tissue site are tissue interface layer 1715, seal layer 1724, and cover 244. However, the constituent members of the covering material 1700 may be sized so that all of the constituent members are in contact with the tissue site.

  In another exemplary embodiment, a method for collecting liquid in a dressing disposed at a tissue site is provided. The method includes applying a reduced pressure to the tissue site via the dressing, absorbing liquid from the tissue site, and containing the liquid with the dressing. The method further includes preventing liquid from entering the dressing. In one embodiment, the step of absorbing fluid from the tissue site is performed using an absorbent layer similar to the absorbent layer described herein. The method may further include the step of diverting the vacuum toward the target area of the absorbent layer to increase the absorption efficiency corresponding to the absorbent layer. In addition, the time during which the absorbing layer can distribute the reduced pressure may be increased by diverting the reduced pressure toward the target region.

  Exemplary embodiments of the vacuum dressing described herein may include a diverter layer to ensure uniform pressure distribution when the absorbent layer absorbs liquid. The diverter layer also facilitates efficient use of the absorbent in the dressing. The exemplary embodiment may also include a porous hydrophobic filter that prevents the dressing from entering liquids, such as exudate, into the tube, and helps ensure pressure distribution. In the exemplary embodiment, the structure of the dressing and the order of the layers tend to ensure optimal absorbency of the dressing in combination with the transmission of reduced pressure to the tissue site.

  Current wound dressings are designed to absorb fluids to maintain a moist wound environment while minimizing the risk of maceration, but are unsuitable for proper vacuum delivery It is. Current dressings that are not currently used with reduced pressure typically do not transmit pressure to the tissue site. These current dressings are designed only to absorb liquids and are changed regularly. The dressings described in the exemplary embodiments are adapted to provide treatment and increase absorption with or without reduced pressure so that less severe and less exudative wounds are treated. It can be applied to a wide range of wounds. The dressing described in the exemplary embodiment allows for reduced pressure tissue treatment without affecting the absorbency of the dressing.

  If the direction is not changed by a constituent member such as a diverter layer, the liquid absorbed by the absorption layer may concentrate in a limited area around the exudation point. This may leave a large amount of absorbent layer unused. For example, when a 125 mmHg vacuum source is connected to the vacuum dressing, the absorbent releases a portion of the absorbed liquid, and the released liquid avoids the remaining absorption area, It will be drawn directly into the tube that connects. At this point, the dressing no longer absorbs liquid and as the liquid enters the tube, the ability of the dressing to transmit the reduced pressure to the tissue site is impaired. Furthermore, this phenomenon may occur when only a very small amount of the target liquid is absorbed. However, the use of the divertor layer and other layers described herein increases the efficiency of the absorbent layer so that the vacuum dressing can absorb more liquid and collect the vacuum over a longer period of time. It may become.

  The components of the reduced pressure coating described herein are shown in a non-limiting spatial three-dimensional arrangement, which can be changed according to implementation. In the drawings, the constituent members of the reduced pressure coating material are shown in a specific order, but these constituent members may be in any order depending on the implementation. Similarly, any particular component may be included or excluded depending on the particular application.

Pump-integrated dressing The decompression dressing and components of FIGS. 1-17 have been described so far in a manner adapted to connect to a decompression source external to the dressing. However, the vacuum dressings described herein use an integral pump, i.e., a pump disposed within or between layers of dressings, to deliver reduced pressure through the layers of dressings to the tissue site. It can also be incorporated.

  Referring to FIG. 18, an exemplary embodiment reduced pressure treatment system 1800 includes a reduced pressure dressing 1804 disposed at a patient tissue site 1808. The reduced pressure coating material 1804 includes a reduced pressure pump 1810 integrated with the reduced pressure coating material 1804. In addition to the vacuum pump 1810, other components may be incorporated into the dressing, including but not limited to sensors, processing units, control units, warning indicators, memory, databases, software. Further, the reduced pressure dressing 1804 may include an interface (wireless or wired) that allows fluid communication between components within the dressing 1804 and components that may be external to the dressing 1804. In one non-limiting example, the interface may be a USB port. External components include, but are not limited to, a control unit, a display unit, a charger, and a user interface that further facilitates the application of reduced pressure treatment to the tissue site 1808. When reduced pressure is delivered to the reduced pressure dressing 1804 and the tissue site 1808 by the reduced pressure pump 1810, the blood flow to the tissue around the tissue site is increased while maintaining the discharge of exudate from the tissue site, By generating microstrain, new tissue growth is promoted.

  Referring to FIGS. 19 and 20, the reduced pressure coating material 1804 includes an interface layer 1920 adapted to be disposed at the tissue site 1808, and a seal layer 1922 for sealing the reduced pressure coating material 1804 around the tissue site 1808. Including. A first manifold layer 1924 is disposed in fluid communication with the interface layer 1920 and distributes the vacuum to the interface layer 1920 and the tissue site 1808. An absorbent layer 1928 is disposed in fluid communication with the first manifold layer 1924 and absorbs liquid from at least one of the first manifold layer 1924, interface layer 1920, and tissue site 1808. A diverter layer 1932 is disposed adjacent to the absorption layer 1928. A second manifold layer 1936 is disposed in fluid communication with the diverter layer 1932, and a gas-liquid separator 1940 is disposed adjacent to the second manifold layer 1936. A cover 1944 (or drape) is disposed adjacent to the second gas-liquid separator 1940. An indicator and a deodorizing filter may be disposed in the reduced pressure covering material 1804.

  Each layer of reduced pressure coating 1804 is similar in shape, size, position and function to any other layer of reduced pressure coating described herein. In addition to the layers of vacuum dressing 1804 listed above, the vacuum dressing 1804 also includes a pump 1810 that can be integrated with the dressing between the gas-liquid separator 1940 and the cover 1944. The pump 1810 may be a micropump that is small and lightweight enough to maintain the integrated vacuum dressing 1804 over the tissue site 1808. Further, the size and weight of the pump 1810 should be such that the integrated vacuum dressing 1804 does not tear the tissue site 1808 and otherwise adversely affect the tissue site. In one embodiment, the pump 1810 is a piezoelectric actuator similar to that described in International Patent Application No. PCT / GB2006 / 001487 (published as International Patent Application No. WO2006 / 111775), incorporated herein by reference. It may be a disk pump having In one alternative embodiment, pump 1810 may be a peristaltic pump used to pump various liquids. However, it should be understood that alternative pump technologies can be utilized, and rotary pumps, linear pumps, or other structured pumps can be utilized.

  The pump 1810 may be used to generate a vacuum that is sufficient to make the wound treatment “therapeutic”. In one embodiment, the pump 1810 has sufficient flow, vacuum, and operating life characteristics to allow continuous reduced pressure therapy applications. Flow rate flow characteristics may range from about 5 to 1000 ml / min, vacuum characteristics may range from about 50 to 200 mm Hg, and continuous operating life characteristics may exceed 20 hours. However, it should be understood that alternative ranges may be utilized depending on the structure of the integrated vacuum dressing 1804, the size of the wound, the type of wound, and the like. In one embodiment, multiple pumps may be placed within a single dressing to deliver high flow rates or vacuum levels as needed. Alternatively, in order to optimally configure a combination of a pump and a covering material in accordance with a specific tissue site, a user or a medical staff may be in a state where the user can freely select from pumps having different operation performance and specifications.

  The pump 1810 is placed within the dressing to avoid the use of conduits and external canisters that collect wound exudate. The pump 1810 may include a valve 1950 or an outlet to release air or exhaust from the vacuum dressing 1804. When using the valve 1950, the valve 1950 may be disposed within the opening as long as it may be in fluid communication with the opening 1960 of the cover 1944. Alternatively, the periphery of the discharge port of the pump 1810 may be sealed with a cover 1944 so that the gas from the pump 1810 can be directly discharged through the opening 1960. In the embodiment shown in FIGS. 18-20, the valve or outlet of the pump 1810 is oriented away from the hydrophobic filter so as not to add air to the wound dressing. Air is exhausted through an opening 1960 in the cover 1944, which may include a check valve. Alternatively, air or other gas can be discharged through the gas permeable portion of the cover 1944 as long as the reduced pressure maintaining ability of the cover 1944 is not affected.

  When using a piezoelectric driven pump in the dressing, the piezoelectric actuator corresponding to the pump may be driven at different frequencies to act as a buzzer or vibration warning system. For example, the presence of a leak in the dressing, a change in the vacuum measured by the sensor, an indication that the liquid absorption of the dressing has reached its maximum, which can be indicated by an indicator, or one or more layers no longer have a vacuum A warning system may be used to warn the user of a warning state such as an indication of not efficiently collecting and delivering.

  In order to control the operation of the pump 1810, the control electronic circuit unit 2024 may be utilized. Control electronics 2024 may be analog and / or digital and may be configured with a regulator (not shown) for regulating the speed or duty cycle at which pump 1810 operates. Furthermore, the control electronic circuit unit 2024 may be configured with a controller (not shown) that receives a detection signal from a sensor or a switch (not shown). The sensor is located throughout the integrated vacuum dressing 1804 to sense parameters such as pressure, temperature, humidity, chemistry, odor, or any other parameter that can be utilized to manage and control the pump 1810. You may arrange. In one embodiment, the control electronics 2024 includes a computer processor. Alternatively, the control electronics 2024 may include a programmable gate array. Furthermore, the control electronics 2024 may be composed of analog electronic components. However, it should be understood that the control electronics 2024 may include any form of digital and / or analog components to perform the functionality described herein.

  As understood in the art, when performing reduced pressure wound therapy, there are four basic factors including (i) low pressure, (ii) excessive leakage, (iii) absorbent layer concentration, and (iv) battery condition. Concerned. Therefore, the control electronic circuit unit 2024 monitors each of the four basic elements and turns on a lighting device (not shown) such as a speaker (not shown), a vibrator (not shown), or a light emitting diode (LED). Use electronic devices that can be used to generate warning signals (eg, high-pitched beeps, vibrations, or light) and notify healthcare professionals, patients, and relatives that any parameter is outside the safe range May be included. For example, a continuous sound may be generated when the pressure at the wound site is below the therapeutic level. As another example, a continuous beep sound may be generated when the absorbing layer 1928 is saturated. Moreover, if the battery voltage level drops below a certain level, a different frequency may be generated and / or the LED may be lit. Also, a wide variety of different warning signals may be set to notify the health care professional to take specific action.

  A battery 2026 may be utilized to supply power to the pump 1810 and the control electronics 2024. As described above, the battery 2026 may have any size and shape structure, and may be made of any material such as a polymer so as to adapt to the weight and size of the integrated decompression covering material 1804. . In one embodiment, battery 2026 may be rechargeable. In another embodiment, the battery 2026 may be placed either inside or outside the integrated reduced pressure dressing 1804 and may be placed in a manner that can be easily replaced or charged. In one embodiment, the battery 2026 may be configured with a voltage level sensor (not shown) that is monitored by the control electronics 2024 to measure the power level drop. In one embodiment, battery 2026 may be connected directly to pump 1810. Alternatively, the battery 2026 may be connected to the control electronic circuit unit 2024 that drives the pump 1810 using electric power supplied from the battery 2026. The control electronics 2024 may always supply power and modulation power (eg, pulse width modulation (PWM) signal) to drive the pump 1810.

  The seal layer 1922 may be hung on the integral vacuum dressing 1804, adhered to the cover layer 1944 used to cover otherwise, or otherwise connected. Seal layer 1922 may include an invasive or pharmaceutical grade adhesive that is strong enough to form a vacuum seal with the skin around the patient's wound. Seal layer 1922 is a band having openings 2032 that are slightly larger than the geometric parameters of the hydrophobic filter 2020 or other layers so that the cover layer 2030 may contact the skin around the patient's wound site. Also good. The cover layer 2030 may not be permeable to liquids such as air and liquid. In one embodiment, the cover layer 2030 includes a valve 2034 that allows exhaust from the pump 1810 to be exhausted from the integrated vacuum dressing 1804. The valve 2034 may be a check valve that minimizes liquid mixing into the integrated vacuum dressing 1804 through the cover layer 2030.

  In another embodiment, the seal layer 1922 may be bonded to the diverter layer 1932 and the diverter layer 1932 may be bonded to the cover 1944 to form an upper dressing portion and a lower dressing portion. The upper dressing portion may include a cover 1944, a pump 1810 and related components, a gas-liquid separator 1940, a second manifold layer 1936, and a diverter layer 1932. The lower dressing portion may include an absorbent layer 1928, a first manifold layer 1924, a seal layer 1922, and an interface layer 1920. In one embodiment, the reduced pressure coating material may be configured so that the lower coating material portion can be replaced when the coating material has absorbed the liquid to its maximum capacity. Then, after replacing the lower covering material portion, the upper covering material portion may be reused. This makes it possible to use the pump 1810 a plurality of times while exchanging the disposable part of the covering material. In another embodiment, pump 1810, control electronics 2024, and battery 2026 may be removed from the dressing for reuse and the remaining layers of dressing replaced. In yet another embodiment, only the absorbent layer 1928 may be replaced. In still another embodiment, only the absorbent layer 1928 and interface layer 1920 may be replaced.

  An activated carbon filter 2036 may be used with the integrated reduced pressure dressing 1804 to reduce odor formed from the wound site and dispersed from the unified reduced pressure dressing 1804. Further, an activated carbon filter 2036 may be disposed on a valve or other exhaust port of the pump 1810 in order to filter the exhaust from the pump 1810 before being discharged from the integrated decompression coating material 1804. However, it should be understood that the activation filter 2036 may be selectively configured and arranged above or below the pump 1810. Furthermore, instead of using an activation filter, activated carbon may be incorporated into any or all of the various layers used within the integrated vacuum dressing 1804.

  In another exemplary embodiment, a method of collecting liquid with a dressing disposed at a tissue site includes generating a vacuum using a pump disposed within the dressing. Liquid absorbed from the tissue site is contained in the dressing. Liquid is prevented from entering the pump. The method may further include the steps of maintaining a reduced pressure within the dressing and venting the gas from the pump out of the dressing.

From the foregoing, it should be clear that an invention having significant advantages has been provided. Although the present invention has been illustrated using only a few forms, it is not intended to be limiting and various changes and modifications may be made without departing from the spirit thereof.

Claims (38)

  1. A decompression treatment system,
    A vacuum source;
    A covering material,
    An interface layer adapted to be placed at a tissue site;
    An absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site, the absorbent layer having a peripheral region and a central region ;
    A diverter layer disposed between the absorbent layer and the reduced pressure source, the diverter layer including a plurality of openings in fluid communication with the absorbent layer to distribute reduced pressure to the absorbent layer; The diverter layer is disposed such that the openings are in fluid communication only with the peripheral region of the absorbent layer ;
    And a covering material including a cover disposed on the diverter layer to maintain a reduced pressure at the tissue site.
  2.   2. The reduced pressure treatment system according to claim 1, wherein the interface layer is hydrophobic.
  3.   The reduced pressure treatment system according to claim 1, wherein the absorption layer includes superabsorbent fibers.
  4.   The reduced pressure treatment system according to claim 1, further comprising a gas-liquid separator disposed between the absorption layer and the cover.
  5.   2. The reduced pressure treatment system according to claim 1, wherein a surface area of the diverter layer is larger than a surface area of the cover.
  6. The reduced pressure treatment system according to claim 1, further comprising:
    Comprising a gas-liquid separator disposed between the absorbent layer and the cover;
    The surface area of the diverter is greater than the surface area of the cover;
    At least a part of the cover is adhesively bonded to the diverter, and at least a part of the diverter layer is bonded to a tissue around the tissue site.
  7.   The reduced pressure treatment system according to claim 6, further comprising a seal layer disposed between the diverter layer and a tissue around the tissue site.
  8.   2. The reduced pressure treatment system according to claim 1, wherein the reduced pressure source is a manually operated pump.
  9.   2. The reduced pressure treatment system according to claim 1, wherein an opening of the diverter layer is disposed near at least one peripheral edge of the diverter layer.
  10.   2. The reduced pressure treatment system according to claim 1, wherein at least one of the openings is larger than another opening.
  11.   2. The reduced pressure treatment system according to claim 1, wherein at least one of the openings is configured to contract when exposed to moisture.
  12.   2. The reduced pressure treatment system according to claim 1, wherein the diverter layer includes a plurality of ridges on a surface of the diverter layer, and a plurality of channels are defined between the ridges.
  13.   2. The reduced pressure treatment system according to claim 1, wherein the diverter layer enables the absorption capacity of the absorption layer to be more utilized.
  14.   2. The reduced pressure treatment system according to claim 1, wherein the diverter layer increases the time that the absorbent layer can distribute the reduced pressure.
  15.   2. The reduced pressure treatment system according to claim 1, wherein the diverter layer is gas permeable.
  16. A vacuum dressing adapted to distribute the vacuum to the tissue site,
    An interface layer adapted to be disposed at the tissue site;
    An absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site, the absorbent layer having a peripheral region and a central region ;
    A diverter layer adjacent to the absorbent layer, formed from a substantially gas impermeable material, in fluid communication with the absorbent layer to increase the time that the absorbent layer can dispense a vacuum. look including a plurality of openings are, they opening is in the diverter layer, a substantially peripheral region of the absorbent layer is positioned away from the central region of the absorbent layer, the diverter layer When,
    And a cover disposed on the diverter layer to maintain a reduced pressure at the tissue site.
  17. A vacuum dressing adapted to distribute the vacuum to the tissue site,
    An interface layer adapted to be disposed at the tissue site;
    A first manifold layer disposed in fluid communication with the interface layer to distribute reduced pressure to the interface layer;
    An absorbent layer in fluid communication with the first manifold layer for absorbing liquid from at least one of the first manifold layer, the interface layer, and the tissue site , the peripheral region and the center An absorbent layer having a region ;
    A diverter layer disposed adjacent to the absorbent layer, wherein the diverter layer is formed from a substantially gas impermeable material and is in a plurality of spaced apart fluid communication with the absorbent layer. opening seen including, they opening is in the diverter layer, a vicinity of the peripheral region of the absorbent layer is positioned away from the central region of the absorbent layer, and the diverter layer,
    A second manifold layer in fluid communication with the diverter layer to distribute reduced pressure to the diverter layer;
    A cover for maintaining a reduced pressure at a tissue site, the cover having an opening adapted to deliver the reduced pressure to the dressing;
    A reduced-pressure coating material comprising a gas-liquid separator disposed between the second manifold layer and the cover in order to suppress liquid from entering the coating material.
  18. The reduced-pressure coating material according to claim 17 , wherein the interface layer is hydrophobic.
  19. The reduced-pressure coating material according to claim 17 , wherein the absorption layer includes superabsorbent fibers.
  20. The reduced pressure dressing according to claim 17 is further disposed between the tissue around the tissue site and at least one other layer of the dressing so as to assist in maintaining a reduced pressure within the dressing. A reduced pressure coating material comprising a sealing layer.
  21. The reduced-pressure coating material according to claim 17 , wherein a surface area of the diverter layer is larger than a surface area of the cover.
  22. 18. The reduced pressure coating material according to claim 17 , wherein a surface area of the diverter layer is larger than a surface area of the cover, at least a part of the cover is adhesively bonded to the diverter layer, and at least a part of the diverter layer. Is bonded to a tissue around the tissue site.
  23. The reduced-pressure coating material according to claim 22 , further comprising a seal layer disposed between the diverter layer and a tissue around the tissue site.
  24. 18. The reduced pressure coating material according to claim 17 , wherein an opening of the diverter layer is disposed in the vicinity of at least one peripheral edge of the diverter layer.
  25. The reduced-pressure coating material according to claim 17 , wherein the opening is a hole.
  26. The reduced-pressure coating material according to claim 17 , wherein at least one of the openings is larger than another opening.
  27. The reduced-pressure coating material according to claim 17 , wherein at least one of the openings is configured to contract when exposed to moisture.
  28. 18. The reduced-pressure coating material according to claim 17 , wherein a plurality of ridges are included on the surface of the diverter layer, and a plurality of channels are defined between the ridges.
  29. The reduced-pressure coating material according to claim 17 , wherein the diverter layer makes it possible to more effectively utilize the absorption capacity of the absorption layer.
  30. 18. The reduced pressure coating according to claim 17 , wherein the diverter layer increases the time that the absorbing layer can distribute the reduced pressure.
  31. A vacuum dressing applied to distribute the vacuum to the tissue site,
    An interface layer adapted to be placed at the tissue site;
    An absorbent layer in fluid communication with the interface layer that absorbs liquid from at least one of the interface layer and the tissue site;
    A diverter layer adjacent to the absorbent layer and formed from a substantially gas impermeable material, wherein the flow rate is directed around at least one peripheral edge of the diverter layer and is less than the surface area of the absorbent layer A divertor layer having a surface area;
    And a cover disposed on the diverter layer to maintain a reduced pressure at the tissue site.
  32. 32. The reduced pressure coating material according to claim 31 , wherein the interface layer is hydrophobic.
  33. 32. The reduced-pressure coating material according to claim 31 , wherein the absorption layer includes superabsorbent fibers.
  34. The reduced pressure coating material according to claim 31 , further comprising a gas-liquid separator disposed between the absorption layer and the cover.
  35. 32. The reduced-pressure coating material according to claim 31 , further comprising a seal layer disposed between the cover and a tissue around the tissue site.
  36. 32. The reduced-pressure coating material according to claim 31 , wherein the diverter layer makes it possible to more effectively utilize the absorption capacity of the absorption layer.
  37. The reduced-pressure coating material according to claim 31 , wherein the absorption capacity of the absorption layer is increased.
  38. A vacuum dressing adapted to distribute the vacuum to the tissue site,
    An interface layer adapted to be disposed at the tissue site;
    An absorbent layer in fluid communication with the interface layer to absorb liquid from at least one of the interface layer and the tissue site, the absorbent layer having a peripheral region and a central region ;
    A diverter layer in fluid communication with the absorbent layer, formed from a substantially gas permeable , liquid impermeable material , the diverter layer allowing fluid communication with a peripheral region of the absorbent layer Meanwhile, a diverter layer that substantially prevents fluid communication with the central region of the absorbent layer ;
    And a cover disposed on the diverter layer to maintain a reduced pressure at the tissue site.
JP2010549891A 2008-03-05 2009-03-05 Method for applying pressure to a dressing and a tissue site to collect and contain liquid from the tissue site Active JP5118212B2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US3401308P true 2008-03-05 2008-03-05
US61/034,013 2008-03-05
US4902808P true 2008-04-30 2008-04-30
US61/049,028 2008-04-30
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